German regulator issues six major observations to Dr Reddy’s Duvvada facility

“The auditor has cautioned that the facility will receive EU-GMP certification from the regulator up to November 2018 only when the regulator approves the CAPA,” it stated.Prabha Raghavan | ET Bureau | September 08, 2017, 12:50 IST

“This is to inform you that on 7th September, 2017, the Regulatory Authority of Germany (Regierung von Oberbayern), concluded an audit for our formulations manufacturing facility in Duvvada, Vishakapatnam, with zero critical and six major observations,” Dr Reddy’s told the Bombay Stock Exchange on Friday morning.

Products manufactured at this facility are not currently exported to the EU, the firm added.

The company will be submitting a Corrective and Preventive Action plan (CAPA) to the authorities, Dr Reddy’s said. The Duvvada facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of its EU-GMP certification, it added.

“The auditor has cautioned that the facility will receive EU-GMP certification from the regulator up to November 2018 only when the regulator approves the CAPA,” it stated.

Share prices of Dr Reddy’s on BSE dropped nearly 7% to Rs 2069.10 a piece on Friday morning before it notified the stock exchange of the observations. As of 11:38 am, Dr Reddy’s stock was trading at Rs 2151.10, 3.28% lower than the previous close.

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